Each Panbio™ COVID-19 Antigen Rapid Test box contains 25 tests ($13 per test).
The Panbio™ COVID-19 Antigen Rapid Test is a test used for point-of-care testing (POCT) that detects COVID-19 in 15 minutes. Rapid antigen tests allow for workplaces to proactively identify cases of COVID-19 that may have otherwise been missed, supporting employee safety and business continuity in a variety of settings.
Each Panbio™ COVID-19 Antigen Rapid Test box contains:
- 25 test devices with desiccant in individual foil pouch
- 1 buffer (1 x 9 ml/bottle)
- 25 extraction tubes
- 25 extraction tube caps
- 25 sterilized nasal swabs for sample collection
- 1 positive control swab
- 1 negative control swab
- 1 tube rack
- 1 quick reference guide (nasopharyngeal)
- 1 instructions for use guide
Materials required but not provided:
- Personal protective equipment
- Protective gloves
- Biohazard container
Performance of the Panbio™ COVID-19 Antigen Rapid Test:
- Sensitivity: 98.1% [95% CI: 93.2% -99.8%]
- Specificity: 99.8% [95% Cl: 98.6% - 100.0%]
*Performance determined from 104 positive samples confirmed with nasal PCR using FDA EUA RT-PCR method.
*The clinical performance data was also calculated vs nasopharyngeal swab specimens using an FDA EUA RT-PCR reference and has a sensitivity of 91.1% (95% CI: 84.2-95.6%) and specificity of 99.7% (95% CI: 98.6-100.0%).
When should you perform the Panbio™ COVID-19 Antigen Rapid Test?
- See the Ontario Ministry of Health’s COVID-19 Guidance: Considerations for Rapid Antigen Screening for details regarding the recommended use of the Panbio™ COVID-19 Antigen Rapid Test as a screening tool.
- The Panbio™ COVID-19 Antigen Rapid test should only be used on asymptomatic individuals for screening purposes only.
- The Panbio™ COVID-19 Antigen Rapid test should not be used for diagnosis of COVID-19 infection. It should not be used for symptomatic individuals, or individuals who have had close contact with known positive cases. Symptomatic individuals, or individuals who have had close contact with known positive cases should be directed to an Assessment Centre, participating licensed community lab or specimen collection centre, where available, for testing.
- The Panbio™ COVID-19 Antigen Rapid Test should not be used in either a confirmed or suspected outbreak setting. The local Public Health Unit should be notified in such circumstances.
Who can perform the Panbio™ COVID-19 Antigen Rapid Test?
- Specimen collection and test processing for rapid antigen testing is to be conducted by health professionals, or other trained individuals, in accordance with the manufacturer’s label.
- Specimen collection may also be done by the person being tested (‘self-swabbing’) if a health care professional (regulated or unregulated), or trained individual, is supervising the self-swabbing.
- Any individual supervising self-swabbing must consult the self-swabbing training resource developed by Ontario Health in collaboration with Public Health Ontario and ensure they have the appropriate knowledge, skills, and judgment to provide appropriate self-swabbing oversight, including how to operate the device, personal protective equipment requirements, and how to safely dispose of waste.
How often should someone be screened for COVID-19 using the Panbio™ COVID-19 Antigen Rapid Test?
- The recommended frequency of rapid antigen testing is dependent upon the community prevalence of COVID-19.
- For asymptomatic individuals in high prevalence areas (Yellow/Orange/Red/Grey zones), specimen collection and screening should be performed 2 to 3 times per week.
- For low prevalence areas (Green), specimen collection and screening should be performed 1 to 2 times per week.
How is the Panbio™ COVID-19 Antigen Rapid Test conducted?
Download the Abbott Panbio™ COVID-19 Antigen Rapid Test User Guide. Appropriate biosafety considerations must be addressed when using the Panbio™ COVID-19 Antigen Rapid Test. Refer to Public Health Ontario’s Abbott Panbio™ COVID-19 Antigen Rapid Test: Biosafety Considerations fact sheet for further details.
Process the test according to manufacturer’s instructions. Results are available within 15 minutes. If the results of the Panbio™ COVID-19 Antigen Rapid Test are positive, they are considered preliminary positive and the tested individual should immediately self isolate and will need a regular laboratory-based PCR COVID-19 test to confirm the results within 24 hours.
Cat No/REF: 41FK11 (CE, WHO EUL) Sample Type: Nasal swab Quantity: 25 tests/kit Storage: 2-30°C Shelf Life: 12 months Test Time: 15 minutes. Do not read results after 20 minutes. Multiple Language IFU: English, French, German, Italian, Portuguese, Spanish, Russian
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